Official Title

A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECT/CT Imaging to Detect Clinically Significant Prostate Cancer in Men With Biopsy Proven Low-Grade Prostate Cancer Who Are Candidates for Active Surveillance (proSPECT-AS)

Trial Description

Specificity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B]

Sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B]

Secondary Outcome:

Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]

Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]

Clinical safety of 99mTc-MIP-1404

This is a multi-centre, multi-reader, open-label trial, comparing 99mTc-MIP-1404 SPECT/CT
imaging in men who have had a diagnostic trans-rectal ultrasound (TRUS) guided biopsy with a
histopathologic finding of Gleason score ≤3+4 who are candidates for active surveillance and
are undergoing routine biopsy or voluntary RP with or without a pelvic lymph node dissection
(PLND). This study will evaluate the sensitivity and specificity of 99mTc-MIP-1404 SPECT/CT
image assessments to correctly identify subjects with previously unknown clinically
significant prostate cancer in two cohorts: (1) Low grade prostate cancer who have elected to
undergo RP [Cohort A]; and (2) very low risk (VLR) prostate cancer per 2016 NCCN Guidelines
who are scheduled to undergo routine prostate biopsy [Cohort B].
Subjects will receive a single dose of 99mTc-MIP-1404 Injection (study drug) followed by
whole body planar and SPECT/CT (pelvic) imaging 3-6 hours after injection. In accordance with
standard of care procedures, subjects will undergo either voluntary RP [Cohort A] or prostate
biopsy [Cohort B] within 42 days after study drug dosing. 99mTc-MIP-1404 image data will be
collected by a central imaging core laboratory and evaluated for visible uptake within the
prostate gland. These findings will then be compared against central histopathology as the
truth standard. The central imaging core lab independent readers for the SPECT/CT scans will
be blinded to all clinical data, including pathology results. Likewise, central pathologists
are to remain blinded to all clinical data, including imaging results.